Phthalates, chemical compounds used as plasticizers (softening agents) in a wide variety of products, fall into the category of restricted substances. They are subject to strict limits applied across a range of different legislations which apply in different parts of the world.
EUROPE – REACH Regulation
Annex XVII REACH restricts DEHP, DBP and BBP in concentrations greater than 0.1% by weight of the plasticised material in toys and childcare articles. It also restricts DINP, DIDP and DNOP in concentrations greater than 0.1% by weight of the plasticised material in toys and childcare articles which can be placed in the mouth by children.
On the European Commission website there is a document which has been published on questions and agreed answers on the implementation of Annex XVII of REACH. In this document it states that “different restrictions are applied to each of the two groups of phthalates. The limit value of 0.1% should therefore be applied for each group of phthalates combined, ie the concentration of DEHP, DBP and BBP combined should not be higher than 0.1% and the concentration of DINP, DIDP and DNOP combined should also not be higher than 0.1%.”
For reference see page 12 of the following document:
http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/restr-faq-may-2011_en.pdf
USA
CPSIA (Consumer Product Safety Improvement Act) Section 108 on products containing certain phthalates states that three phthalates, DEHP, DBP, and BBP, have been permanently prohibited by Congress in concentration of more than 0.1% in “children’s toys” or “child care articles.” Three additional phthalates, DINP, DIDP, and DnOP, have been prohibited pending further study and review by a group of outside experts and the Consumer Product Safety Commission (CPSC). This interim prohibition applies to child care articles or toys, that can be placed in a child’s mouth or brought to the mouth and kept in the mouth so that they can be sucked or chewed, that contain a concentration of more than 0.1% of the above phthalates.
On the CPSC website in the frequently asked questions section it states that the 0.1% limit for the six banned phthalates applies to each individual phthalate, not the total amount of these phthalates in the product.
For reference see http://www.cpsc.gov/about/cpsia/faq/108faq.html
The Office of Environmental Health Hazard assessment (OEHHA) states that Proposition 65 applies to all products, not just children’s products, and is intended to provide information to Californian citizens on exposure any of the 800+ chemicals listed which are known to cause cancer, birth defects or other reproductive harm.
The following phthalates are listed under Proposition 65:
- Di(2-ethylhexyl) phthalate (DEHP)
- Butyl benzyl phthalate (BBP)
- Di-n-butyl phthalate (DBP)
- Di-isodecyl phthalate (DIDP)
- Di-n-hexyl phthalate (DnHP) (Not AB 1108 or CPSIA listed)
Under Proposition 65, significant exposure to any one of these named phthalates would require a warning prior to the exposure. ”Safe harbor levels” for DEHP, DBP, and DnHP have been established which indicate when a Proposition 65 warning is required.
More information about safe harbor levels, including a list of all available safe harbor levels may be found here: http://www.oehha.ca.gov/prop65/getNSRLs.html
Phthalates in products are also subject to other federal and state laws. The California phthalates in children’s toys law (AB 1108, 2007) bans the use of certain phthalates (DEHP, BBP, DBP, DIDP, DINP and DnOP) in excess of 0.1 percent in certain child care articles. Information on the State of California Department of Justice website supports the fact that the AB 1108 follows European requirements and as such we believe the same ruling in terms of the application of the limits for the grouped phthalates should apply.
For information about the implementation of the California phthalate law, visit the State Attorney General’s Office web site at http://ag.ca.gov/prop65/pdfs/CA_phthalate_letter.pdf.
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